(106 days)
Not Found
G940032
No
The device description focuses on mechanical components and control systems without mentioning any AI/ML capabilities for analysis, decision-making, or image processing.
Yes
The device is described as "ablating occlusive material and restoring luminal patency" in patients with atherosclerotic disease, which directly treats a medical condition.
No
The device description clearly states its purpose is to "restore luminal patency" by ablating occlusive material, which is a treatment rather than a diagnostic function.
No
The device description details numerous hardware components including a burr, drive shaft, air turbine, guide wire, sheath, advancer, console, foot pedal, and compressed gas system. This is clearly a hardware-based medical device with some software control (the console).
Based on the provided information, the Rotablator system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease." This describes a procedure performed on a patient's body, not a test performed on a sample taken from a patient.
- Device Description: The description details a mechanical system with a rotating burr designed to physically ablate material within blood vessels. This is a therapeutic intervention, not a diagnostic test.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The Rotablator system is a therapeutic medical device used for treating occlusive atherosclerotic disease.
N/A
Intended Use / Indications for Use
The Rotablator system is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for bypass graft surgery or percutaneous transluminal angioplasty.
Product codes
Not Found
Device Description
The Rotablator Rotational Angioplasty System uses a high speed, rotating, diamondcoated burr to ablate occlusive material and restore luminal patency. The burr spins at 140,000-190,000 RPM and ablates material into very fine particles that are carried distally and removed via the reticuloendothelial system. The burr is driven by a flexible helical drive which has a central lumen through which a guide wire passes. The drive shaft is connected to an air turbine which is powered by compressed air or nitrogen.
The guide wire that is used with this system can be separately advanced and steered past an occlusive lesion. The guide wire has a radiopaque spring tip that facilitates its passage through the vasculature, minimizes trauma to the vessel, and makes its progress visible.
The sheath covering the drive shaft protects arterial tissue from the spinning drive shaft and permits the passage of saline to lubricate and cool the spinning drive.
The advancer functions as a housing for the air turbine and as for the sliding elements that control burr extension.
The console monitors and controls the votational speed of the burr and continuously provides the operator with herformance information during the procedure. The console has two modes of operation: a high speed for ablation and a lower speed for catheter exchange.
The foot pedal is the on/off control for the advancer air turbine and is mounted in a protective shroud to inhibit accidental actuation. The pedal is fitted with a valve that vents any compressed gas left in the foot pedal hose when the pedal is released, permitting rapid stopping of the burr. The foot pedal also has a toggle switch for activating and deactivating the lower speed catheter exchange.
The compressed gas system consists of a regulator mounted on a compressed gas cylinder and a supply hose leading to the control console inlet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In Vitro Tests:
A series of bench tests were done that characterize the performance of the HTI guide wires in a clinical setting. The results of these tests indicate that the HTI guide wires are safe and reliable.
Tests included:
- Tensile Force (weld joint, solder joint)
- Torque Strength (turns to failure)
- Torqueability (proximal to distal turns)
- Tip Flexibility (cantilevered 1.5", 3.1", 6.1")
- Wear Test: All wire configurations passed wear test. Success criteria: (1) guide wire does not fail catastrophically, and (2) at end of two minute test, advancer speed ≥ 150,000 RPM.
- Heart Model: In this qualitative assessment of pushability and steerability the Floppy and Floppy II were compared to Type C, and the Standard was compared to Type A. All A Plus wires were found more maneuverable than the Types A and C.
Clinical Tests:
The clinical investigation included 147 sequentially enrolled patients with coronary artery disease between July 1994 and December 1994. The inclusion and exclusion criteria are consistent with the Investigational Plan previously submitted in G940032. The contraindications and precautions are consistent with the approved Instructions for Use for the Rotablator System.
Descriptive statistical analysis showed that the complication rates associated with the use of the HTI guide wires and the Types A and C guide wires are not significantly different with the exception of spasm, abrupt closure post catheterization lab, and access site bleeding of significance. These complications are not considered to be related to the guide wire. It may be hypothesized that the increase in these complications can be attributed to the patient population characteristics. No patients were discontinued from the study. There was one guide wire fracture during the investigation.
Although these clinical data are from coronary use of the Rotablator system, the conclusions of safety and efficacy also apply to the peripheral Rotablator system since the coronary procedure represents a worst case situation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
G940032
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).
0
TABLE OF CONTENTS 510(k) SUMMARY
| A. | . 2
Introduction |
|----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. | 2
Device Description |
| C. | Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
| D. | Comparison to Predicate Device
4 |
| E. | In Vitro Tests
5 |
| F. | Clinical Tests
1 |
e
1
510(k) for Peripheral Rotablator® Rotational Angloplasty System with the HTI Guide Wire Line
510(k) SUMMARY
Introduction A.
This 510(k) is for a new line of guide wires which are designed for use with the Rotablator• Rotational Angioplasty System.
| Submitter: | Heart Technology, Inc.
17425 N.E. Union Hill Road
Redmond, WA 98052 | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact: | Diane Johnson
Phone: (206) 556-1541
Fax: (206) 558-1400 | |
| Device Common Name: | Rotational Angioplasty System
Guide Wires | |
| Device Proprietary Name: | Rotablator Rotational Angioplasty System
Rotablator System's Guide Wire Line: HTI Floppy; HTI
Floppy II; HTI Standard | |
| Classification Name: | Catheter, Peripheral, Atherectomy (per 21 CFR 870.4875)
Guide Wire, Angiographic, Accessory | |
| Classification Panel: | Cardiovascular | |
| Manufacturing Facilities: | Heart Technology Manufacturing, Inc.
2515 140th Avenue NE.
Bellevue, WA 98005
and
17425 N.E. Union Hill Road
Redmond, WA 98052 | |
Device Description 8.
The Rotablator Rotational Angioplasty System uses a high speed, rotating, diamondcoated burr to ablate occlusive material and restore luminal patency. The burr spins at 140,000-190,000 RPM and ablates material into very fine particles that are carried distally and removed via the reticuloendothelial system. The burr is driven by a flexible helical drive which has a central lumen through which a guide wire passes.
6
2
The drive shaft is connected to an air turbine which is powered by compressed air or nitrogen.
The guide wire that is used with this system can be separately advanced and steered past an occlusive lesion. The guide wire has a radiopaque spring tip that facilitates its passage through the vasculature, minimizes trauma to the vessel, and makes its progress visible.
The sheath covering the drive shaft protects arterial tissue from the spinning drive shaft and permits the passage of saline to lubricate and cool the spinning drive.
The advancer functions as a housing for the air turbine and as for the sliding elements that control burr extension.
The console monitors and controls the votational speed of the burr and continuously provides the operator with herformance information during the procedure. The console has two modes of operation: a high speed for ablation and a lower speed for catheter exchange.
The foot pedal is the on/off control for the advancer air turbine and is mounted in a protective shroud to inhibit accidental actuation. The pedal is fitted with a valve that vents any compressed gas left in the foot pedal hose when the pedal is released, permitting rapid stopping of the burr. The foot pedal also has a toggle switch for activating and deactivating the lower speed catheter exchange.
The compressed gas system consists of a regulator mounted on a compressed gas cylinder and a supply hose leading to the control console inlet.
3
510(k) for Peripheral Rotablator® Rotational Angloplasty System with the HTI Page 4 Guide Wire Line
Intended Use C.
The Rotablator system is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for bypass graft surgery or percutaneous transluminal angioplasty.
Comparison to Predicate Device D.
The Rotablator system's new HTI guide wires are substantially equivalent to the currently marketed Type A and Type C guide wires. The differences in the HTI wires compared to the currently marketed Types A and C are summarized in Table 1. The indications for use remain the same. No change to the Rotablator advancericatheter or the console is being proposed.
| Feature | Types A and C | HTI |
|---|---|---|
| Wire Profile | Linear taper in the distal | |
| 1.60" | Compound tapered profile | |
| in the distal 18.0" | ||
| Wire Material | 304 Stainless Steel | 304 Stainless Steel |
| Spring Tip Material | Pt-8%W alloy | Pt-8%W alloy or |
| Pt-10%Ni alloy | ||
| Spring Tip Length | Type A 1.05" | |
| Type C 1.40" | Floppy .85" | |
| Floppy II 1.10" | ||
| Standard .85" | ||
| Spring Tip Inner | ||
| Diameter | .0090" | .0055 to .0060" |
| Spring Tip Outer | ||
| Diameter | 0.017" | 0.014" |
Table 1. Design Comparison of Types A and C, and HTI Guide Wires
4
510(k) for Peripheral Rotablator® Rotational Angioplasty System with the HTI Page 5 Guide Wire Line
In Vitro Tests E.
A series of bench tests were done that characterize the performance of the HTI guide wires in a clinical setting. The results of these tests indicate that the HTI guide wires are safe and reliable. Test results are summarized in Table 2.
In addition to the tests summarized in Table 2, toxicity tests were completed on a Pt-10%Ni alloy because this material was chosen as an alternative to the Pt-8%W alloy currently used for the spring tips in HTI's guide wires.
c
5
| Floppy | Floppy II | Standard | Type A | Type C | |
|---|---|---|---|---|---|
| Tensile Force (grams) | |||||
| a) weld joint | |||||
| b) solder joint | a) 315 | ||||
| b) 1132 | a) 364 | ||||
| b) 1373 | a) 603 | ||||
| b) 1837 | a) 182 | ||||
| b) 2384 | a) No Test | ||||
| b) No Test | |||||
| Torque Strength (turns to failure) | 11.6 | 9.7 | 15 | No Test | 18.8 |
| Torqueability1 | |||||
| (proximal to distal turns) | 1.75 to 1 | No Test | 2 to 1 | 3.25 to 1 | No Test |
| Tip Flexibility (mm) | |||||
| a) cantilevered 1.5"; force =.18 gm | |||||
| b) cantilevered 3.1"; force =.18 gm | |||||
| c) cantilevered 6.1"; force =.16 gm | a) 15.7 | ||||
| b) 44.0 | |||||
| c) 97.8 | a) 20.7 | ||||
| b) 47.5 | |||||
| c) 102.9 | a) 14 | ||||
| b) No Test | |||||
| c) No Test | a) 6.0 | ||||
| b) 25.1 | |||||
| c) 76.2 | a) 19.0 | ||||
| b) 20.0 | |||||
| c) 71.1 | |||||
| Wear Test | All wire configurations passed wear test. Success criteria: (1) guide wire does not fail catastrophically, and (2) at end of two minute test, advancer speed ≥ 150,000 RPM. | ||||
| Heart Model | In this qualitative assessment of pushability and steerability the Floppy and Floppy II were compared to Type C, and the Standard was compared to Type A. All A Plus wires were found more maneuverable than the Types A and C. |
Table 2. Engineering Test Comparison of Types A and C, and HTI Guide Wires
A one-to-one torque response is desirable, that is, for one revolution of the proximal end (outside the body), the distal spring tip in the vessel should also rotate once.
1
i
6
Clinical Tests ட்
The clinical investigation included 147 sequentially enrolled patients with coronary artery disease between July 1994 and December 1994. The inclusion and exclusion criteria are consistent with the Investigational Plan previously submitted in G940032. The contraindications and precautions are consistent with the approved Instructions for Use for the Rotablator System. The patients' demographic characteristics are similar to those in the study involving the originally approved guide wires, although the current population includes patients with more pronounced risk factors.
Descriptive statistical analysis showed that the complication rates associated with the use of the HTI guide wires and the Types A and C guide wires are not significantly different with the exception of spasm, abrupt closure post catheterization lab, and access site bleeding of significance. These complications are not considered to be related to the guide wire. It may be hypothesized that the increase in these complications can be attributed to the patient population characteristics. In general, the Rotablator system is currently utilized more often to treat complex lesions (as compared to the original PMA population). It has been shown that both procedural success and complications are a function of lesion classification.2 Because lesions were characterized differently in the two studies, it is not possible to directly compare lesion dassification between the current study and the previous study. However, the lesion characteristics indicate that the current lesions would fall into a higher lesion classification than those in the original PMA population.
No patients were discontinued from the study. There was one guide wire fracture during the investigation. Although these clinical data are from coronary use of the
સ
Ellis, et al, Circulation, Vol 89, No 2, Feb 1994. Relation of Clinical Presentation, Stenosis, Morphology, and Operator Technique to the Procedural Results of Rotational Atherectorny Facilitated Angioplasty.
7
510(k) for Peripheral Rotablator® Rotational Angloplasty System with the HTT Guide Wire Line
Rotablator system, the conclusions of safety and efficacy also apply to the peripheral Rotablator system since the coronary procedure represents a worst case situation.
Rotablator system since the coronary procedure represents a worst case situation.
The preceding summaries demonstrate that the design of the HTI guide wires is a The preceding summance control.
robust, and that they are capable of performing satisfactorily with the Rotablator robust, and that they are capable of the Type A and Type A and Type C guide wires that are currently used.